This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

22339

Vol. 68, No. 81

Monday, April 28, 2003

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. 2001–NE–50–AD] 

RIN 2120–AA64 

Airworthiness Directives; Dowty 

Aerospace Propellers Type R321/4–82–

F/8, R324/4–82–F/9, R333/4–82–F/12, 

and R334/4–82–F/13 Propeller 

Assemblies

AGENCY: Federal Aviation 

Administration, DOT.

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: The Federal Aviation 

Administration (FAA) proposes to 

supersede an existing airworthiness 

directive (AD), applicable to Dowty 

Aerospace Propellers Type R334/4–82–

F/13 propeller assemblies. That AD 

currently requires a one-time ultrasonic 

inspection of propeller hubs part 

number (P/N) 660709201 for cracks. 

This proposal would require initial and 

repetitive ultrasonic inspections of 

propeller hubs P/N 660709201, that are 

installed on airplanes, and for hubs and 

propellers in storage, initial ultrasonic 

inspection of propeller hubs before 

placing in service. Propeller hubs P/N 

660709201 are installed on Type R321/

4–82–F/8, R324/4–82–F/9, R333/4–82–

F/12, and R334/4–82–F/13 propeller 

assemblies. This proposal is prompted 

by the manufacturer’s reevaluation of 

potential hub failure on Type R321/4–

82–F/8, R324/4–82–F/9, R333/4–82–F/

12, and R334/4–82–F/13 propeller 

assemblies. The actions specified by the 

proposed AD are intended to prevent 

propeller hub failure due to cracks in 

the hub, which could result in loss of 

control of the airplane.

DATES: Comments must be received by 

June 27, 2003.

ADDRESSES: Submit comments in 

triplicate to the Federal Aviation 

Administration (FAA), New England 

Region, Office of the Regional Counsel, 

Attention: Rules Docket No. 2001–NE–

50–AD, 12 New England Executive Park, 

Burlington, MA 01803–5299. Comments 

may be inspected at this location, by 

appointment, between 8 a.m. and 4:30 

p.m., Monday through Friday, except 

Federal holidays. Comments may also 

be sent via the Internet using the 

following address: 9-aneadcomment@faa.gov. Comments sent 

via the Internet must contain the docket 

number in the subject line. 

The service information referenced in 

the proposed rule may be obtained from 

Dowty Propellers, Anson Business Park, 

Cheltenham Road East, Gloucester GL 

29QN, UK; telephone 44 (0) 1452 

716000; fax: 44 (0) 1452 716001. This 

information may be examined, by 

appointment, at the FAA, New England 

Region, Office of the Regional Counsel, 

12 New England Executive Park, 

Burlington, MA.

FOR FURTHER INFORMATION CONTACT:

Frank Walsh, Aerospace Engineer, 

Boston Aircraft Certification Office, 

FAA, Engine and Propeller Directorate, 

telephone (781) 238–7158, fax (781) 

238–7170.

SUPPLEMENTARY INFORMATION:

Comments Invited 

Interested persons are invited to 

participate in the making of the 

proposed rule by submitting such 

written data, views, or arguments as 

they may desire. Communications 

should identify the Rules Docket 

number and be submitted in triplicate to 

the address specified above. All 

communications received on or before 

the closing date for comments, specified 

above, will be considered before taking 

action on the proposed rule. The 

proposals contained in this action may 

be changed in light of the comments 

received. 

Comments are specifically invited on 

the overall regulatory, economic, 

environmental, and energy aspects of 

the proposed rule. All comments 

submitted will be available, both before 

and after the closing date for comments, 

in the Rules Docket for examination by 

interested persons. A report 

summarizing each FAA-public contact 

concerned with the substance of this 

proposal will be filed in the Rules 

Docket. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

submitted in response to this action 

must submit a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to 

Docket Number 2001–NE–50–AD.’’ The 

postcard will be date stamped and 

returned to the commenter. 

Availability of NPRM’s 

Any person may obtain a copy of this 

NPRM by submitting a request to the 

FAA, New England Region, Office of the 

Regional Counsel, Attention: Rules 

Docket No. 2001–NE–50–AD, 12 New 

England Executive Park, Burlington, MA 

01803–5299. 

Discussion 

On January 18, 2002, the FAA issued 

AD 2002–01–28, Amendment 39–12623 

(67 FR 4351, January 30, 2002), to 

require a one-time ultrasonic inspection 

for cracks of the rear wall of the rear half 

of propeller hubs P/N 660709201, 

installed in Type R334/4–82–F/13 

propeller assemblies. The Civil Aviation 

Authority (CAA), which is the 

airworthiness authority for the United 

Kingdom (UK), notified the FAA that an 

unsafe condition may exist on Dowty 

Aerospace Propellers Type R334/4–82–

F/13 propeller assemblies. The CAA 

advises that two different events 

occurred where the complete R334/4–

82–F/13 propeller separated from the 

engine flange, on Construcciones 

Aeronauticas, S.A. (CASA) 212 

airplanes. 

Since AD 2001–01–28 was issued, the 

manufacturer has reevaluated the 

potential for P/N 660709201 hub failure 

on Type R321/4–82–F/8, R324/4–82–F/

9, R333/4–82–F/12, and R334/4–82–F/

13 propeller assemblies. 

Manufacturer’s Service Information 

Dowty Aerospace Propellers has 

issued Mandatory Service Bulletin 

(MSB) No. 61–1119, Revision 3, dated 

March 8, 2002, MSB No. 61–1124, 

Revision 1, dated October 8, 2002, MSB 

No. 61–1125, Revision 1, dated October 

9, 2002, and MSB No. 61–1126, 

Revision 1, dated October 9, 2002, that 

specify initial and repetitive ultrasonic 

inspections of the rear wall of the rear 

half of the propeller hub for cracks on 

Types R334/4–82–F/13, R333/4–82–F/

12, R321/4–82–F/8, and R324/4–82–F/9 

propeller assemblies, respectively. The 

CAA classified these service bulletins as 

mandatory and issued CAA UK AD No. 

003–11–2001, dated November 30, 2001, 

in order to assure the airworthiness of 

22340 Federal Register / Vol. 68, No. 81 / Monday, April 28, 2003 / Proposed Rules 

these Dowty Aerospace Propellers in the 

UK. 

Differences Between This AD and the 

Manufacturer’s Service Information 

Although Appendix A of MSB No. 

61–1119, Revision 3, dated March 8, 

2002, MSB No. 61–1124, Revision 1, 

dated October 8, 2002, MSB No. 61–

1125, Revision 1, dated October 9, 2002, 

and MSB No. 61–1126, Revision 1, 

dated October 9, 2002, require reporting 

the inspection data to Dowty Aerospace 

Propellers, this AD requires that the 

data be reported to the Boston Aircraft 

Certification Office of the FAA.

Bilateral Agreement Information 

These propeller models are 

manufactured in the UK and are Type 

certificated for operation in the United 

States under the provisions of Section 

21.29 of the Federal Aviation 

Regulations (14 CFR 21.29) and the 

applicable bilateral airworthiness 

agreement. Pursuant to this bilateral 

airworthiness agreement, the CAA has 

kept the FAA informed of the situation 

described above. The FAA has 

examined the findings of the CAA, 

reviewed all available information, and 

determined that AD action is necessary 

for products of this Type design that are 

certificated for operation in the United 

States. 

Proposed Requirements of This AD 

Since an unsafe condition has been 

identified that is likely to exist or 

develop on other Type R321/4–82–F/8, 

R324/4–82–F/9, R333/4–82–F/12, and 

R334/4–82–F/13 propeller assemblies of 

the same Type design that are used on 

airplanes registered in the United States, 

the proposed AD would require initial 

and repetitive ultrasonic inspections of 

propeller hubs P/N 660709201, that are 

installed on airplanes, and for hubs and 

propellers in storage, initial ultrasonic 

inspection of propeller hubs before 

placing in service. Propeller hubs P/N 

660709201 are installed on Type R321/

4–82–F/8, R324/4–82–F/9, R333/4–82–

F/12, and R334/4–82–F/13 propeller 

assemblies. The actions would be 

required to be done in accordance with 

the mandatory service bulletins 

described previously. 

Economic Analysis 

There are approximately 116 

airplanes with propellers of the affected 

design in the worldwide fleet. The FAA 

estimates that 10 airplanes with Type 

R334/4–82–F/13 propeller assemblies 

installed on airplanes of U.S. registry 

would be affected by this proposed AD. 

It is unknown how many Type R321/4–

82–F/8, R324/4–82–F/9, and R333/4–

82–F/12 propeller assemblies are 

installed on airplanes of U.S. registry. 

The FAA also estimates that it would 

take approximately 11 work hours per 

propeller to perform one inspection and 

replacement, and that the average labor 

rate is $60 per work hour. Required 

parts would cost approximately $1,650 

per propeller. Based on these figures, 

the total cost of the proposed AD to 

known U.S. operators is estimated to be 

$46,200. 

Regulatory Analysis 

This proposed rule does not have 

federalism implications, as defined in 

Executive Order 13132, because it 

would not have a substantial direct 

effect on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, the FAA has not consulted 

with state authorities prior to 

publication of this proposed rule. 

For the reasons discussed above, I 

certify that this proposed regulation (1) 

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under the DOT 

Regulatory Policies and Procedures (44 

FR 11034, February 26, 1979); and (3) if 

promulgated, will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. A copy of the draft 

regulatory evaluation prepared for this 

action is contained in the Rules Docket. 

A copy of it may be obtained by 

contacting the Rules Docket at the 

location provided under the caption 

ADDRESSES.

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety.

The Proposed Amendment 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the Federal Aviation 

Administration proposes to amend part 

39 of the Federal Aviation Regulations 

(14 CFR part 39) as follows:

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended] 

2. Section 39.13 is amended by 

removing Amendment 39–12623, (67 

4351, January 30, 2002), and by adding 

a new airworthiness directive:

Dowty Aerospace Propellers: Docket No. 

2001–NE–50–AD. Supersedes AD 2002–

01–28, Amendment 39–12623.

Applicability: This airworthiness directive 

(AD) is applicable to Dowty Aerospace 

Propellers Type R321/4–82–F/8, R324/4–82–

F/9, R333/4–82–F/12, and R334/4–82–F/13 

propeller assemblies with propeller hubs part 

number (P/N) 660709201. These propeller 

assemblies are installed on, but not limited 

to, Construcciones Aeronauticas, S.A. 

(CASA) 212, British Aerospace Regional 

Aircraft Jetstream Models 3101 and 3201, 

Merlin IIIC, and Merlin IVC/Metro III 

airplanes.

Note 1: This airworthiness directive (AD) 

applies to each engine identified in the 

preceding applicability provision, regardless 

of whether it has been modified, altered, or 

repaired in the area subject to the 

requirements of this AD. For engines that 

have been modified, altered, or repaired so 

that the performance of the requirements of 

this AD is affected, the owner/operator must 

request approval for an alternative method of 

compliance in accordance with paragraph (f) 

of this AD. The request should include an 

assessment of the effect of the modification, 

alteration, or repair on the unsafe condition 

addressed by this AD; and, if the unsafe 

condition has not been eliminated, the 

request should include specific proposed 

actions to address it.

Compliance: Compliance with this AD is 

required as indicated, unless already done. 

To prevent propeller hub failure due to 

cracks in the hub, which could result in loss 

of control of the airplane, do the following: 

Initial Ultrasonic Inspection 

(a) Within 50 flight hours time-in-service 

(TIS) after the effective date of this AD, or 

within 60 days after the effective date of this 

AD, whichever occurs earlier, perform an 

initial ultrasonic inspection of the rear wall 

of the rear half of the propeller hub for cracks 

in accordance with Appendix A of the 

applicable Dowty Aerospace Propellers 

Mandatory Service Bulletin (MSB) listed in 

the following Table 1:

TABLE 1.—APPLICABLE MSB FOR

PROPELLER TYPE

Propeller assembly type Applicable MSB 

(1) R334/4–

82–F/13.

MSB No. 61–1119, Revision 

3, dated March 8, 2002. 

(2) R333/4–

82–F/12.

MSB No. 61–1124, Revision 

1, dated October 8, 2002. 

(3) R321/4–

82–F/8.

MSB No. 61–1125, Revision 

1, dated October 9, 2002. 

(4) R324/4–

82–F/9.

MSB No. 61–1126, Revision 

1, dated October 9, 2002. 

(b) For hubs and propellers in storage, 

perform an initial ultrasonic inspection of the 

rear wall of the rear half of the propeller hub 

for cracks, before placing in service, in 

accordance with Appendix A of the 

applicable Dowty Aerospace Propellers 

Mandatory Service Bulletin (MSB) listed in 

Table 1 of this AD. 

(c) Propeller hubs P/N 660709201 used on 

Type R334/4–82–F/13 propeller assemblies 

Federal Register / Vol. 68, No. 81 / Monday, April 28, 2003 / Proposed Rules 22341

that have been previously inspected using 

Dowty Aerospace Propellers MSB No. 61–

1119, Revision 3, dated March 8, 2002, or 

earlier issue, are considered to be in 

compliance with paragraph (a) of this AD. 

Repetitive Ultrasonic Inspections 

(d) Thereafter, within 1,000 flight hours 

TIS after each ultrasonic inspection, perform 

an ultrasonic inspection of the rear wall of 

the rear half of the propeller hub for cracks 

in accordance with Appendix A of the 

applicable Dowty Aerospace Propellers MSB 

listed in Table 1 of this AD. 

Inspection Reporting Requirements 

(e) For each inspection, record the 

inspection data on a copy of Appendix B of 

the applicable MSB listed in Table 1 of this 

AD, and report the findings to the Manager, 

Boston Aircraft Certification Office, FAA, 

Engine and Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803–5299 within 10 days after the 

inspection. Reporting requirements have 

been approved by the Office of Management 

and Budget (OMB) and assigned OMB control 

number 2120–0056. 

Alternative Methods of Compliance 

(f) An alternative method of compliance or 

adjustment of the compliance time that 

provides an acceptable level of safety may be 

used if approved by the Manager, Boston 

Aircraft Certification Office. Operators must 

submit their request through an appropriate 

FAA principal Maintenance Inspector, who 

may add comments and then send it to the 

Manager, Boston Aircraft Certification Office.

Note 2: Information concerning the 

existence of approved alternative methods of 

compliance with this airworthiness directive, 

if any, may be obtained from the Boston 

Aircraft Certification Office.

Special Flight Permits 

(g) Special flight permits may be issued in 

accordance with §§ 21.197 and 21.199 of the 

Federal Aviation Regulations (14 CFR 21.197 

and 21.199) to operate the airplane to a 

location where the requirements of this AD 

can be done.

Note 3: The subject of this AD is addressed 

in CAA UK AD 003–11–2001, dated 

November 30, 2001.

Issued in Burlington, Massachusetts, on 

April 22, 2003. 

Robert Guyotte, 

Acting Manager, Engine and Propeller 

Directorate, Aircraft Certification Service.

[FR Doc. 03–10334 Filed 4–25–03; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 106 and 107

[Docket No. 95N–0309]

RIN 0910–AA04

Current Good Manufacturing Practice, 

Quality Control Procedures, Quality 

Factors, Notification Requirements, 

and Records and Reports for the 

Production of Infant Formula; 

Reopening of the Comment Period

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Proposed rule; reopening of the 

comment period.

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

June 27, 2003, the comment period for 

the proposed rule, published in the 

Federal Register of July 9, 1996 (61 FR 

36154), revising its infant formula 

regulations in 21 CFR parts 106 and 107. 

The proposed rule would establish 

requirements for current good 

manufacturing practice (CGMP) and 

audits, establish requirements for 

quality factors, and amend its quality 

control procedures, notification, and 

records and reports requirements for 

infant formula. FDA is reopening the 

comment period to update comments 

and to receive any new information.

DATES: Submit written or electronic 

comments by June 27, 2003.

ADDRESSES: Submit written comments 

to the Dockets Management Branch 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Shellee Anderson, Center for Food 

Safety and Applied Nutrition (HFS–

800), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1491, or e-mail: 

Shellee.Anderson@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Reopening of Comment Period

In the Federal Register of July 9, 1996 

(61 FR 36154), FDA proposed 

regulations (the 1996 proposal) to revise 

its infant formula regulations to 

establish requirements for quality 

factors and CGMP; to amend its quality 

control procedure, notification, and 

records and report requirements for 

infant formulas; to require that infant 

formulas contain, and be tested for, 

required nutrients and for any nutrient 

added by the manufacturer throughout 

their shelf life, and that they be 

produced under strict microbiological 

controls; and to require that 

manufacturers implement the CGMP 

and quality control procedure 

requirements by establishing a 

production and in-process control 

system of their own design. The agency 

proposed these requirements to 

implement provisions of the Drug 

Enforcement, Education and Control Act 

of 1986 (Public Law 99–570) that 

amended section 412 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 350a).

Interested persons were originally 

given until October 7, 1996, to comment 

on the 1996 proposal. However, at the 

request of a trade organization, the 

comment period was extended to 

December 6, 1996 (61 FR 49714, 

September 23, 1996).

FDA’s Food Advisory Committee 

(FAC) met on April 4 and 5, 2002, to 

discuss general scientific principles 

related to quality factors for infant 

formula. The committee was also asked 

to discuss the scientific issues related to 

the generalization of findings from a 

clinical study using preterm infant 

formula consumed by preterm infants to 

a term infant formula intended for use 

by term infants. On November 18 and 

19, 2002, the Infant Formula 

Subcommittee (IFS) of the FAC met to 

discuss the scientific issues and 

principles involved in assessing and 

evaluating whether a ‘‘new’’ infant 

formula supports normal physical 

growth in infants when consumed as a 

sole source of nutrition. The 

Contaminants and Natural Toxicants 

Subcommittee (CNTS) of the FAC met 

on March 18 and 19, 2003, to discuss 

the scientific issues and principles 

involved in assessing and evaluating 

Enterobacter sakazakii contamination in 

powdered infant formula, risk reduction 

strategies based on available data, and 

research questions and priorities. 

Information on these three meetings, 

including the agenda, questions asked, 

guest speakers, committee roster, 

briefing information, and transcripts of 

the meetings can be found at http://

www.fda.gov/ohrms/dockets/ac/

cfsan02.htm.

II. Request for Comments

Because of the length of time that has 

elapsed since publication of the 1996 

proposal and the occurrence of the FAC, 

IFS, and CNTS meetings, FDA is 

interested in updating comments and 

receiving any new information before 

issuing a final rule. Accordingly, the 

agency is requesting comments on all